We are currently recruiting ME/CFS patients AND Healthy Controls for this completely web based study to create a one of a kind genetic database for individuals with ME/CFS.

Participation for this study requires you to have a computer with internet access, an email account and your agreement to map your genes through the use of a publicly available genetic testing websites. If you agree to participate, you will provide us with your raw genetic data for us to compile in a one of a kind, ME/CFS Genetic Database.

Besides providing us with your genetic data, participants will be completing online surveys at your own pace. As all communication is done via secure email server, NO travel is necessary and participation can be done in the comfort of your home!

"We request your participation in a telebriefing about updates on NIH’s efforts to advance research on ME/CFS. The telebriefing will be held on November 28, 2017, 1:00 until 2:00 pm ET. If you will be calling from the U.S., please use the following dial-in information for the telebriefing.

Dial-in: 877-951-7311Participant passcode: 8394694If you will be calling from another country, please see the attached chart for your country’s access information.

Please remember to register at NIHME CFSWorkingG@ninds.nih.gov if you plan to participate in the call.

Thank you in advance for your participation and we look forward to an engaging, thoughtful and productive conversation.

Would a prestigious national institution invite a Holocaust denier to speak about World World II, or a member of the KKK to speak about race relations?

We can't know what they were thinking when the NIH extended their invitation to Dr. Shorter, who is certainly no expert on any aspect of ME/CFS. But we do know that inviting a man who is so outspoken in his absolute denial of the disease reflects very poorly on the attitudes of the institution that recently pledged to take ME/CFS "very seriously."

You can read more about Dr. Shorter's invitation as well as his disparagement of ME/CFS patients HERE.

Dr. Shorter is scheduled to speak on November 9. Please send a letter to your representative today.______________________________From Solve ME/CFS Initiative

BREAKING NEWS: Last week, deeply troubling information was discovered on an archived National Institutes of Health (NIH) webpage. A lecture titled “Chronic Fatigue Syndrome in Historical Perspective” is scheduled for Wednesday, November 9, to be presented by the controversial and inflammatory history professor Edward Shorter, PhD.

A professor of psychiatry and history at the University of Toronto, Shorter is an outspoken skeptic about the biological nature of ME/CFS. He has referred to the disease as both a “psychodrama” and a “psychic epidemic” and called the findings of the Institute of Medicine’s report on ME/CFS last year “junk science.”

Please note that this action is for REPRESENTATIVES ONLY, NOT SENATORS.

Please call the Washington DC office, not the district office, and ask to speak to the legislative assistant for health. If the legislative assistant is not available, you can ask to leave a message or immediately ask for the e-mail address of the legislative assistant to send him or her your request in writing.

Feel free to tell the legislative assistant your story, but remember to be very brief. Use the sample script below as a guide.

My name is _________. I’m a constituent in {city}. I am calling with an urgent request for Representative {NAME} to contact the National Institutes of Health. The NIH has invited an inflammatory and controversial speaker, Dr. Shorter, who denies that ME/CFS is a physical disease. Between 1 to 2.5 million Americans like me [or my family member] who are afflicted with the horrific, disabling, and costly disease myalgic encephalomyelitis, also known as chronic fatigue syndrome or ME/CFS. ME/CFS has no known cause, cure, diagnostic test, or FDA-approved treatment, and it often leaves patients bedridden for decades. Please urge Representative {NAME} to support patients and voice their concern about this troubling speaker who calls me [or my family member] “delusional.” May I have your e-mail address to send you additional information?

If you do not receive an e-mail address for a particular staffer, ask for the general comment e-mail address.Step 2: E-mail your representativeAfter you speak to the staff person by phone, it is always helpful to follow up with an e-mail. Download a helpful ME/CFS issue fact sheet here (http://solvecfs.org/wp-content/uploads/2016/11/SMCI-NIH-Response-Flaws-Flier.pdf) to include with your e-mail. Feel free to personalize the e-mail below.

Dear Congress Member [LAST NAME],

As a constituent and as a (caregiver to / loved one of) a patient with myalgic encephalomyelitis (ME), commonly known as chronic fatigue syndrome (CFS), I am bringing your attention to the immediate need for Congress to assist ME/CFS patients. In September, 55 bipartisan members of the House of Representatives joined together to write to NIH Director Francis Collins regarding ME/CFS. That letter was not enough, and we need your help now.As you may know, ME/CFS is a complex disease with no known cause, treatment, diagnostic tool, nor cure. The CDC estimates that up to 2.5 million Americans suffer from ME/CFS, and patients have lower quality of life scores than those with lung cancer, stroke, and rheumatoid arthritis. According to the 2015 Institute of Medicine Report on ME/CFS, the disease costs the U.S. economy an estimated $17-$24 billion per year.

And the NIH continues to disregard the legitimate needs of ME/CFS patients. On Wednesday, November 9, the NIH’s clinical center is scheduled to host a lecture given by Dr. Edward Shorter, a historian at the University of Toronto and one of the most controversial and inflammatory figures to the ME/CFS patient community. This man, despite overwhelming scientific evidence, does not believe ME/CFS is an actual disease—instead calling it a “psychic epidemic” perpetrated by “moaning and groaning victims” who are “delusional.” Dr. Shorter has written pieces so disparaging of patients that they were removed from circulation by Psychology Today.

The NIH is clearly not prioritizing a solution to ME/CFS when they provide a forum for a speaker who demeans patients and denies scientific findings. I am asking you to please stand with patients who are very ill with this very REAL physiological disease, as verified by thousands of published scientific articles.​Please contact NIH Director Francis Collins and ask him to

Present scientifically grounded information to NIH researchers. If the NIH insists on including an inflammatory and controversial speaker who offers no scientific rigor, please balance this with an opposing expert such as Mary Dimmock, author of 30 Years of Disdain: How HHS and a Group of Psychiatrists Buried Myalgic Encephalomyelitis.

Reaffirm the findings of the Institute of Medicine report that ME/CFS is a true physiological disease, not a psychological one.

Prioritize ME/CFS funding with substantial investment commensurate with the burden of this devastating disease.

Only continued oversight from you and your colleagues in Congress will induce the NIH to take the actions necessary to help patients.

Very truly yours,

(NAME)

Step 3: Let us know how it wentE-mail our advocacy and engagement manager, Emily Taylor (etaylor@solvecfs.org), to let us know your member of Congress received the message.

Thank you for doing your part to advocate on behalf of all the patients who suffer with this disease.

The IACFS/ME (International Association for CFS and ME) Conference is held every other year. This year it was held on October 27-30, at the Westin Fort Lauderdale Beach Resort in Fort Lauderdale, Florida.

This conference is a huge event, attracting researchers and clinicians from all over the world. There are workshops, presentations, poster sessions and numerous networking events. It is an exciting gathering, and a wonderful opportunity to hear the latest in ME/CFS research.

Traditionally, Dr. Komaroff gives a summary of the notable research presented at the conference. ​Mary Schweitzer has generously provided the summary below with this note: This is my best effort of transcribing Komaroff’s summary of the 2016 meeting - feel free to repost.

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Komaroff summary of 2016 IACFS/ME meeting

In the past two years, since the 2014 SF meeting the report of the IOM based on a review of other 9.000 published articles concludes that ME/CFS is a “biologically-based illness”

Announcement of expanded research activities by the National Institutes of Health and educational efforts by the Centers for Disease Control and Prevention.

Detailed analysis of the components of “post-exertional malaise” (Stanford)- Physical and cognitive exertion trigger PEM more often than emotional distress.- PEM includes not only fatigue, but also cognitive difficulties, sleep disturbances, headaches, muscle pain and flu-like symptoms- PEM lasts 3 or more days in approximately 25% of people.

Exercise testing in patients with ME?CFS vs. healthy controls:- Triggers a characteristic gene expression “signature” involving 15 cytokines/adipokines/growth factors (Stanford)- When repeated 24 hours after a first exercise test leads to a significant decline in peak heart rate (“chronotropic incompetence”), which could contribute to post-exertional malaise (U of the Pacific)- Leads to postural tachycardia after exercise (as contrasted to after tilt table testing) in a subset of ME/CFS patients and Gulf War Illness patients, due to increased sympathetic activity (Georgetown)

Exercise testing in patients with ME/CFS vs. healthy control subjects:- Leads to lower oxygen consumption and earlier conversion to anaerobic metabolism (Nova and Wisconsin)- Blood lactate levels in 2nd exercise test after 24 hours- ME/CFS patients lactate levels are higher at all work loads- Healthy controls: lactate leels are lower at all work loads.

Immunology:

Huge study: 192 cases, 392 healthy controls.- Levels of 17/51 cytokines/adipokines/growth factors were significantly different in ME/CFS than healthy controls- Most of the cytokines were pro-inflammatory, and their levels correlated significantly with the severity of symptoms (Stanford University)

Interesting because many clinicians and researchers in this field have long believed that the disease was caused by abnormal cytokines in the brain.

- Synthesize molecules of inflammation (cytokines, prostaglandins) and elicit the production of those molecules by the gut immune system- Through inflammation, create a “leaky gut”: the tight junctions that bind gut epithelia cells together become loosened – allowing bacteria and bacterial toxins to enter the blood.

In addition to the recently-reported reduction in bacterial diversity in ME/CFS, the team reports finding an increased number of Caudovirales bacteriophage viruses in ME/CFS.

All of these findings point to low-level inflammation in the gut. (Cornell)

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Brain and Nervous System

- Impaired speed in processing information is shown to be a critical deficit in both ME/CFS and Gulf War Illness- Compared to healthy children, pediatric patients with ME/CFS had impaired information processing speed and attention. After exertion, these deficits worsened and ME/CFS kids also had poorer performance on tasks of working memory.- Impairments in cerebral blood flow and cortical glutathione levels – not affected by comorbid psychiatric disease.- A third of ME/CFS, but no healthy controls, had high white cell count or elevated protein in spinal fluid.- Altered heart rate variability, due to reduced cardiac vagal activity, in ME/CFS v. healthy controls. [There is some evidence that this can be a sign or contributory factor to heart disease later.]

Functional connectivity among different brain regions impaired:- Followed a cognitive test in ME/CFS v. healthy controls, determined by PET- As determined by diffusion MRI in GWI patients- As determined by EEG (eLORETTA) in ME/CFS patients at rest

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Epigenetic studies- Disease is caused not just by mutated genes- It also is caused by perfectly normal, non-mutated genes, when those genes are not “expressed” (turned on or off) appropriately- Gene expression is controlled by many different “epigenetic” forces- Epigenetic studies are increasingly being done in ME/CFS v. healthy control- ME/CFS: genes involved in signal transduction are hypomethylated more often, whereas genes involved in cell differentiation/cell death are hypermethylated more often- ME/CFS: significantly different gene expression patterns for genes, involved in immune regulation (JAK-STAT pathway), hormone regulation and mitochondrial dysfunction.- Gulf War Illness: 19 related groups of genes (“functional modules”) were found to have significantly altered gene expression. Specific immunosuppressant and hormonal therapies were identified that might target these dysregulated genes, and possibly improve symptoms.- ME/CFS patients, compared to healthy controls, have 13 different gene loci, all involving glucocorticoid sensitivity that are differentially methylated. The different methylation patterns correlated with clinical symptoms- Characteristic expression of two particular microRNAs in plasma leads to elevated homocysteine levels identified in ME/CFS- Three SNPs distinguished ME/CFS patients from healthy controls. All involve a gene that codes for a subunit of NADH dehydrogenase – an important energy molecule.- MicroRNAs in spinal fluid predict orthostatic tachycardia after exercise.- No clear gene expression differences in ME/CFS v. healthy controls, at rest.

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Energy Metabolism Studies- Studies on patients in the rituximab trial have an energy metabolism deficit, and the key molecule is the enzyme pyruvate dehydrogenase (PDH). Speculate that autoantiboedies may be the cause of this deficit. Upregulation of PDH inhibitors in white blood cells (Norway group – study will finish late 2017)- Peripheral white blood cells from ME/CFS produce energy less well than WBCs from healthy subjects, particularly when the cells are exposed to stressors.- Citric acid cycle metabolites are depleted. Glucose as an energy source is being replaced by fatty acids and amino acids- “Unbiased” metabolomics study finds that the metabolites that are most different between ME/CFS and healthy controls involve pathways harvesting energy from glucose, fatty acids and amino acids.- Also finds a general hypometabolic state, as did the recent paper from Naviaux (PNAS), though different metabolites were examined.

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Miscellaneous- ME/CFS patients, but not healthy controls, experience a worsening of symptoms following true (but not sham) strain: neuromuscular strain (even sitting/driving for prolonged time) may contribute to symptoms of ME/CFS. Physical therapy likely to help- Five specific findings on physical examination were quite accurate in diagnosing ME/CFS. This is of interest, since ME/CFS is defined exclusively by symptoms.- Of over 200 single-nucleotide polymorphisms examined, three – all located in the gene for NADH dehydrogenases – were significantly different in ME/CFS patients than in healthy controls.- ME/CFS patients have significantly higher anti-citrullinated protein antibodies than matched healthy controls, as is seen in the autoimmune whatever.- Particular mutations in two nucleosome transport genes distinguish ME/CFS patients from healthy controls.- A second case of ME/CFS caused by an enteroviral infection of the brain.- Impressive hypothesis: dysregulation in the production/release of Hydrogen Sulfide could explain many of the symptoms and objective abnormalities seen in ME/CFS- A subset of ME/CFS patients with sinusitis and/or hives has more pain and other symptoms

An ideal diagnostic test would:· Have very low false positive and false negative rates, compared to healthy controls and other fatiguing disease, when retested on a large number of new people· Be easy for perform reliably by many labs· Be inexpensive

Treatment Studies

· MRI spectroscopy revealed 15% lower levels of the natural antioxidant, glutathione, in the brain in ME/CFS patients compared to controls. N-acetyl-cysteine (NAC) treatment improved both brainglutathione levels and symptoms, and reduced oxidative stress, in the ME/CFS patients· Randomized trial of low-dose methylphenidate plus a nutritional regimen designed to improve mitochondrial function. At 12 weeks, a trend toward reduced symptom that was not statistically significant; more severely ill patients seemed to benefit· A careful study of 990 ME/CFS patients found that patient beliefs about the cause of their illness did not explain their level of activity, a result that does not support the theoretical benefit of cognitive behavioral therapy.· Multimodel physical therapy improves symptoms in adolescents and young adults with ME/CFS and impaired range of motion.· Quantitative modeling identifies drug that are already FDA-approved and that might target TNA-alpha, IL-2 and the glucocorticoid receptor – targets that may be important in causing the symptoms of GWI

Questions addressed by many presentations:· In an illness defined exclusively by subjective symptoms, is there evidence of underlying biological abnormalities?· Could those biological abnormalities theoretically explain the symptoms?· Do the abnormalities in fact correlate with the symptoms?

On September 27, ME Action sponsored the second Millions Missing global event. (The first was in May 2016.)

The purpose of the Millions Missing events was to draw public attention to ME/CFS, to demand increased funding into research for biomarkers and for effective treatment, and to improve medical education and patient care. (You can read the demands HERE.)

The global day of protest was a resounding success, with demonstrations in twenty-five cities in ten countries, and more being planned. The Millions Missing events drew ample media attention, as well as interest from government representatives and hundreds of passersby who saw the moving displays of empty shoes and stopped to talk to the volunteers – both patients and supporters – who dedicated their day to this worldwide effort.

I have selected some representative photos below, but to get the full impact of the event, I encourage you to browse ME Action's gallery of inspiring photos HERE.

Please donate to this admirable initiative! This is the first time that there has been a coordinated international movement to bring attention to this disease, and to raise awareness at such an impressive scale. Millions Missing deserves our whole-hearted support!

ATLANTA​In Atlanta, Georgia, a group gathered at the State Capitol to give speeches about personal tragedies, the history of ME/CFS and hopes for a new science leading to a brighter future. State Representative Michael Caldwell was present and several other Representatives and staffers stopped by to listen and learn.

BOSTON​Patients and supporters met in front of the JFK building to raise awareness for ME/CFS. They laid out shoes, handed out flyers, displayed posters, and chatted with passersby. A couple of patients did performance pieces!

CHICAGO​Over 70 patients gathered outside the James Thompson Center in Chicago. Carol Head spoke as a patient and the president of SolveME/CFS Initiate stating "we will no longer be ignored." She focused her speech on the Institute of Medicine's report. Leonard Jason spoke about the severity of the disease and Marcie Zinn described the brain research she is working on at DePaul University in Chicago.

DALLAS​Eight people attended the Millions Missing protest at Dallas City Hall Plaza. A 25-foot banner was displayed among posters and photos of patients who were unable to attend. The protest demands were read and posted on Facebook live.

LANSING​The Lansing #MillionsMissing protest was held on the East steps of the Michigan State Capitol building, and several local news crews were present. Nineteen attendees from all over Michigan held signs and sat on the steps under a large banner. Patients shared their stories, and there was a long moment of silence for those who have died and those who are bed-bound.

MORRISTOWN​In Morristown, NJ, the demonstration lasted from 3:30 - 8:30 PM. Many people stopped by to learn more about ME/CFS, as well as the lack of funding and support from the NIH, CDC and HHS. The patients who were able to stop by were very grateful for this initiative.

NEW YORK​The NYC protest had approximately forty people in attendance with a full agenda of speakers. Dr. Susan Levine, Dr. Mady Hornig, Jim Eigo (ACT UP/NY), Annette Gaudino (Treatment Action Group), ME Activist Terri L. Wilder as well as other people living with and affected by ME spoke at the demonstration. A few reporters showed up and at the end of the demonstration Terri and Annette attempted to deliver a "bad report card" to the HHS regional office director but were stopped by building security and threatened with a citation! (See pictures in NYC photo folder HERE.)

After tweeting "at" Jackie Cornell, HHS Regional 2 District Director, and asking her what she has done for New Yorkers with ME, ME Activist Terri Wilder received a private tweet from Ms Cornell stating "I'd love to sit down and discuss. I'm in DC a few days of this week and next but please email me and we can set up a time. Thank you for your advocacy and reaching out!"

NORTHAMPTON​About a dozen patients and supporters gathered in front of City Hall in Northampton, MA. Passersby stopped to look at the display of shoes on the steps of City Hall, as well as read handouts and talk about ME/CFS with demonstrators. Lisa Hall, RN, from Northampton Wellness Associates gave a speech about the countless patients with ME/CFS she has seen, and described the severity of the disease. One patient spontaneously went into the town hall to invite the mayor to come down and visit. He did, and after speaking with the demonstrators offered a City Proclamation making May 12 official recognition day for ME/CFS.

Well over 100 people showed up for the Millions Missing day of action in San Francisco. Over 150 patient profiles were stretched across 120 feet and a 60-foot quilt made over 17 years ago was displayed. The quilt was a created in three countries as a desperate plea for visibility and funding.

Hundreds of individuals passed these displays, many of them stopping to look for several minutes and ask demonstrators about the illness. Patient Sonya Heller Irey gave a passionate speech about the devastation this disease can inflict on an individual. A proclamation provided by Mayor Ed Lee was announced, naming a day of Awareness for ME in San Francisco, and a certificate of honor was issued by the San Francisco board of supervisors in recognition of the advocacy of the Millions Missing campaign.

Groundbreaking ME/CFS researchers, Dr. Eric Gordon, Dr. Ron Davis, and Dr. Jose Montoya, attended this event. Dr. Eric Gordon talked about potentially having a biomarker in the near future based on the recent metabolomics study.

“CFS/ME has devastated the lives of millions of people worldwide. The pain, suffering and solitude that this disease has brought to so many human beings is immeasurable. For the past 35 years, CFS / ME patients have been ignored, humiliated, misdiagnosed, mistreated and told that the disease is the product of their imagination. As a clinician investigator at Stanford University, when I close my eyes and I see the disease in all its enormity and complexity, I can only conclude that this is likely one of the greatest medical and scientific detective stories we face in the 21st century,” said Jose Montoya, professor at the Stanford University Medical Center.

Dr. Ron Davis added. “Unfortunately this [protest] is really necessary…. NIH funding gives you a steady state level of funding for five years so you can plan and you can hire people and you can do a much more effective job of doing the research... it’s not about doing one study, it’s about a sustained effort to figure it out and that’s why we need government funding in this project.

SEATTLE​Demonstrators handed out flyers and held up signs for about two hours while passersby stopped to talk. Those who stopped were saddened and surprised by the fact that many people get so ill they can no longer work at all and stay in bed most of the day. It was a wonderful opportunity to come together to spread awareness of this debilitating disease.

WASHINGTON, D.C.​A large protest was held at the U.S. Department of Health and Human Services in Washington. Speakers included Ryan Prior and Hillary Johnson. Laura Benson and her husband, a retired Air Force officer, also gave compelling speeches. Three journalists covered the event, and the Montgomery County Council (home of NIH) issued a proclamation supporting ME/CFS awareness day.

LONDON​“The day was in equal measures surreal, empowering, saddening and desperately emotional. The sense of brotherhood felt almost palpable as we stood together and spoke about our experiences with ME – our personal struggles, our deepening concern over graded exercise trials, particularly in children, and how one mother now cares for her husband and two children, all of whom suffer from ME.

We were grateful to have been live a total at least three, perhaps even four times throughout the protest thanks to London Live News (footage to follow) as well as grasp the attention of hundreds of passers-by with our strong words, our prominent display of shoes, and of course, our naked protester holding up the sign, You can’t ignore ME now.”

BELFAST​Dozens of shoes were laid out at Stormont, the seat of the Northern Ireland Assembly. Twenty-seven protestors held signs, including Sally Burch, long-time patient and Trustee of Hope 4 ME and Fibro. According to the Telegraph, Ulster Unionist health spokeswoman Jo-Anne Dobson MLA hosted the campaign. She said: "The sheer passion and drive of campaigners on display today at Stormont must be met by real and positive change in the treatment of thousands of patients across Northern Ireland."

Bristol displayed 150 shoes on College Green in central Bristol, for a day of protest on behalf of the Millions Missing. ME patients, loved ones and family members gave out leaflets and talked to passersby, most of whom were visibly shocked to learn the truth about this devastating illness. One individual stayed for almost an hour reading every single label on every pair of shoes. Many wanted to donate to fund research.

CARDIFF​The Millions Missing event in Cardiff was held on the steps of the Welsh Assembly that looks out over Cardiff Bay. Rows of empty shoes were a very poignant reminder of what the demonstration was all about. The Cardiff Rock Choir volunteered their services free of charge and drew the attention of passersby. A dance trio also performed, adding to the day.

A number of Assembly Members came out to speak with the demonstrators, including Julie Morgan who sponsored the group. Jan Hutt Assembly Member for the Vale of Glamorgan also came out onto the steps of the Assembly to speak to the demonstrators. Other Assembly Members stopped to find out more about Millions Missing, including Vikki Howells AM for Cynon Valley, David Melding AM for South Wales Central, and Dai Lloyd AM for South Wales West.

Press: Made in Cardiff TV came to film the event and presented a good report at 6 pm and 9 pm on their Tuesday evening News.

NOTTINGHAM​About 15 patients, family and friends gave out 200 flyers, spoke to 300 people, and got 30 signatures to stop GET trials on children. A passing ME patient couldn't believe that someone was standing up for ME "as people never do anything for us."

Press: BBC Nottingham Radio, covered on news bulletins throughout the day and had a 10-minute segment (about 5:20) as part of drive show (prime driving home from work time)

BBC East Midlands Today covered the demonstration on local TV news on the evening news segment. They filmed at the event and at a patient’s home.

OXFORD

The Oxford event took place in front of the Radcliffe Camera Landmark. Over 100 pairs of shoes were laid out. Volunteers helped to hand out around 200 leaflets and explained ME to curious passersby, many of whom stopped to read the shoe tags describing each sufferer's experience with ME.

Patients and relatives met at the Hamburg harbor to raise awareness of ME/CFS. People came from all parts of the country and there was huge virtual support.

“ME/CFS must be considered as a severe physical illness. It’s time to take us seriously!” said Daniel from the German Society of ME/CFS. Nicole from the Lost Voices Foundation pointed out that “Patients are left alone! This day is so important for us to raise awareness of ME and to eventually improve overall care and treatment.”

THE HAGUE, NETHERLANDS​A Millions Missing protest was held from 10:00 AM to 4:00 PM in front of Parliament in The Hague. About 1000 pairs of shoes were displayed, which drew the attention of many visitors. Fifteen demonstrators handed people flyers and talked with them about ME. Dr. Frans Visser gave a speech. The group spoke to two members of Parliament from two different political parties.

Demonstrators in Oslo displayed 250 pairs of shoes and spoke with 300 passersby. Olaug V. Bollestad, a member of Parliament, and two speakers from patient organizations gave speeches. Three musicians performed. One patient group brought fruit and yoghurt for the participants to tide them through the event. The participants intend to start a collaboration with the Norwegian research fundraising group to help fundraise for clinical studies here in Norway.

Press: The demonstrators were interviewed by a national radio station at 3pm and filmed all day by a documentary filmmaker who is creating a documentary about ME and the Rituximab study in Norway. The film will come out in 2018. The event was filmed live and had about 120 people watching the live feed.

The recently formed ME/CFS Foundation South Africa held a virtual event. They asked patients for their stories and photos of shoes/activities they could no longer participate in, made posters, and posted these throughout the day on Facebook, posted on Twitter, sent the virtual event to numerous online newspapers. They also texted and emailed radio presenters throughout the day.

Press: Shoes for a Syndrome....................................................................................................................

After dogged work by advocates, fifty-five members of Congress have added their signatures to a letter initiated by representatives Zoe Lofgren (D - CA) and Anna Eshoo (D - CA).

The letter urges NIH to respond in a timely fashion to requests for grants. It also asks NIH to report its efforts to fund research as well as the status of specific plans for funding over the next two years.

​Congressional support is crucial for obtaining funding for research because unlike agencies, which are beyond our influence, representatives have an obligation to support the interests of their constituents.____________________

Advocates Obtain Congressional Support for Strengthened ME/CFS Research at NIH

LOS ANGELES, September 9, 2016 – After years of neglect by the National Institutes of Health (NIH), patients suffering from myalgic encephalomyelitis (ME), commonly known as chronic fatigue syndrome (CFS), created a win today as members of Congress came together urging the NIH to do the right thing and strengthen ME/CFS research.

In a formal U.S. House of Representatives letter published today (“the letter”), 55 members of Congress called upon NIH Director Francis Collins to strengthen the NIH’s efforts in ME/CFS biomedical research through a reinvigorated trans-NIH ME/CFS working group as well as additional intramural and extramural research programs.

As the letter explains, “ME/CFS is a complex, debilitating, and chronic disease afflicting 1 to 2.5 million Americans. It costs individuals, the U.S. health care system, and our economy an estimated $17-$24 billion annually. Yet, as the Institute of Medicine noted in its report, ‘Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness,’ there has been ‘remarkably little research funding’ to date to discover its cause or possible treatments.”

Thanks to the hard work of #MEAction, the Solve ME/CFS Initiative (SMCI), and dozens of independent advocates, the letter attracted a broad coalition of bipartisan cosigners led by U.S. Representatives Zoe Lofgren and Anna Eshoo of California. In addition to encouraging advocates all across the country to reach out to their own representatives, SMCI President Carol Head also wrote a personal letter to all 435 representatives, urging them to sign onto the letter.

Said SMCI President Carol Head, “The NIH has failed to live up to its commitment to ME/CFS patients and has not followed the recommendations put forth in the 2015 IOM report; now, thanks to the actions of a coalition of hardworking advocates and members of Congress, we expect this to change.”

The Solve ME/CFS Initiative (SMCI) was founded in 1987 and has established itself as the leading non-profit organization dedicated to ME/CFS. The organization’s mission is to make ME/CFS widely understood, diagnosable, and treatable by stimulating and conducting research aimed at the early detection, objective diagnosis, and effective treatment of ME/CFS. SMCI is the first and only ME/CFS organization to earn the highest possible distinction (a 4-star rating) from Charity Navigator, America’s largest independent charity evaluator.

OnAugust 16, the First Tier Tribunal (UK) ordered the release of the PACE Trial data to Alem Matthees, marking the end of a two-year battle. (You can read the order HERE.)

Mr. Matthees is an Australian researcher, and ME/CFS patient, who has made repeated attempts under the Freedom of Information Act to obtain anonymized data from the PACE trial. Queen Mary University of Londom (QMUL) has managed to quash every request - until now.

In this historic ruling, the tribunal determined that:

1) The information Mr. Matthees requested is not personal, and therefore an exemption based on the possibility that people in the trial could be identified does not apply.

2) Because data are anonymized, invasion of privacy does not apply.

3) There is no indication that the release of anonymized data would discourage future research.

4) There is a strong public interest in releasing the data.

This last point is especially important, as it directly addresses the issue of transparency in research, a topic that has been much in the news lately.

In a 2005 article published in PLoS ONE, Stanford professor John Ionnides claimed that most published research findings were false. There are a number of reasons why research is falsified, including outright plagiarism, conflict of interests (especially true in cases where research is being paid for by pharmaceutical companies), poor methodology, scientific malfeasance, false premises, and general incompetence.

In the case of the PACE trial, conflict of interests led directly to scientific malfeasance. The conflict here stemmed from the unwillingness of NHS to pay for treatment for ME patients. In comparison to treatments such as Ampligen, IVIG, and other immunotherapies, cognitive behavior therapy (CBT) and graded exercise (GET) are relatively cheap to administer.

The PACE trial is not the first trial to make the claim that CBT and GET are beneficial for ME/CFS patients. Trudie Chalder, one of the principals in the PACE study, has been publishing articles since 1989 touting the benefits of CBT and exercise for ME/CFS patients. Nor is she a stranger to faulty methodology as the statistics on some of these studies were questionable.

The PACE trial was the crowning glory to over two decades of research for Chalder, as well as for several other psychiatrists involved in the study. While it is unlikely QMUL will spend any more money on challenging the tribunal's decision, it is equally unlikely that the PACE trial group will abandon its "research" into CBT and GET. In fact, a second PACE study involving adolescents is already under way.

_______________________

Press Release from ME Action:

Thursday, 18th August 2016, London, UK - A tribunal has ruled that data from a treatment trial intoChronic Fatigue Syndrome (CFS) must be released, rejecting an appeal from Queen Mary Universityof London (QMUL).

PACE was a £5 million, publicly-funded clinical trial of exercise and cognitive behavioural therapy for CFS. It has been highly influential in determining treatment in the UK and abroad, but has beencontroversial. Academics and patients have both voiced concerns over “misleading” claims. DrRichard Smith, former editor of the British Medical Journal, said in December 2015 of QMUL’s failure to release the data, “…the inevitable conclusion is that they have something to hide”.

QMUL spent over £200,000 on legal fees in this case, to appeal the Information Commissioner’sdecision that they should release anonymised data from the trial. The request for data was madeunder the Freedom of Information Act by Mr Alem Matthees, to allow analysis of the data accordingto the study’s original published protocol.

QMUL made several arguments why the data should not be released, their main claims being thatthe data was personally identifiable information, and was not sufficiently anonymised. However, thetribunal rejected these arguments, noting that QMUL had already shared the data with a smallselection of other scientists, stating, "In our view, they are tacitly acknowledging that anonymizationis effective, or else they would be in breach of the consent agreement and the DPA principles."

The tribunal was satisfied that the data “...has been anonymised to the extent that the risk ofidentification is remote.” The tribunal also noted the "strong public interest in releasing the datagiven the continued academic interest" and "the seeming reluctance for Queen Mary University toengage with other academics they thought were seeking to challenge their findings."

In his correspondence with the court, Mr Matthees expressed “concerns that QMUL are restrictingthe registered researchers to whom they disclose the data upon request.” The tribunal said, “Theevidence before us is not clear but if QMUL are cherry-picking who analyses their data from withinthe recognised scientific research sphere to only sympathetic researchers, there could be legitimateconcerns that they wish to suppress criticism and proper scrutiny of their trial.”

In its submissions QMUL made a number of accusations of harassment from patients, while QMUL’sexpert witness characterized PACE trial critics as "young men, borderline sociopathic orpsychopathic", remarks the Information Commissioner dismissed as "wild speculations".

When pushed to provide evidence of these threats and harassment under cross examination,witnesses speaking for QMUL were unable to do so, and ultimately conceded that "no threats havebeen made either to researchers or participants."

The tribunal found QMUL's assessment of activist behaviour to be, “grossly exaggerated” statingthat “the only actual evidence was that an individual at a seminar had heckled Professor Chalder.”[Professor Chalder is a leading researcher in the PACE trial and a key witness for QMUL.]

Expert reaction to the decision

Jonathan C.W. Edwards, MDEmeritus Professor of MedicineUniversity College London

“I think this is the right decision and I congratulate Mr Matthees on persevering with a veryreasonable request. The report indicates that the Tribunal considered arguments from both sidesvery thoroughly. It has become clear that the reasons given for not providing the informationrequested are essentially groundless. It is also clearly appreciated that critics of the PACE trial arenot young sociopaths - they include senior medical scientists like myself, concerned about poorscience!”

“I am heartened by the Tribunal’s finding that the Commissioner had reached a correct decision inordering release of anonymized data for the PACE trial. The Tribunal’s assessment that theperceived risks of data release were neither substantiated nor demonstrated in the evidence beforethem and that such minimum risk as had been expressed to them would not in their view outweighthe public interest in disclosure of the disputed information is quite important, not only for patientsin this trial and around the world, but also because it underscores how essential transparency andopen, critical review of clinical trials are to the scientific method.”

Keith Geraghty, PhDHonorary Research FellowUniversity of Manchester

"I read the tribunal decision with great interest. I was surprised that the PACE authors declared inevidence that they had shared their trial data with other researchers. I contacted lead author Prof.Peter White to request access to PACE data to run an independent analysis, but my request was firstignored, then later refused. I now understand that the authors shared the data with a select fewacademics who they picked to co-write papers, but they have failed to share the data with thebroader scientific community. Selectively sharing this publicly-funded data with collaborators butrefusing to share data with anyone else, is not in the best interests of patients or science, and itcreates a perception that the PACE team do not want independent critical analysis of this trial. I findit regrettable that the Medical Research Council, who partly funded this very expensive study, didnot specify that the trial data be made available to other researchers.”

This means that there can now be an independent analysis of data from the PACE trial that has beenused to support a number of conclusions and recommendations regarding the benefits of CBT andGET in ME/CFS that are just not consistent with patient evidence for these interventionsHaving attended the hearing, where a number of unsubstantiated and serious accusations weremade against the patient community, I am pleased to see that this 'red herring' was also rejected bythe tribunal. I hope that QMUL will now accept this judgement to release the data and do so without further delay and that they will not spend any more public money on an appeal.”

David Tuller, DrPH, Investigative journalist and public health expertUniversity of California, Berkeley

"This decision is a thorough repudiation of the efforts by the PACE investigators to protect theirclaims and findings from being exposed as utter nonsense. You don't actually need the data todetermine that the trial is a piece of garbage, but having the data at last will make it clear toeveryone. They will likely appeal, but they will ultimately lose."

Alem MattheesPatient and Second RespondentAustralia

I am very pleased with this outcome. Both the Tribunal’s decision and commentary are a longoverdue victory for the patient community, as well as for advocates of clinical trial transparency andopen data sharing. I want to thank everyone who gave support, advice or assistance, as well asanyone who engaged in debate over the PACE trial and the sharing of clinical trial data. This caseended up costing me greatly in time, energy, and health (currently bedridden).

I utilised the FOIA to loosen the vice grip control over the data and allow truly independent and openanalyses that do not rely on the approval of QMUL or the PACE trial investigators. All this cameabout largely because of their refusal to publish or release the protocol-specified outcomes, andtheir generally questionable and poorly or erroneously justified changes to the published trialprotocol, i.e. outcome switching, after the trial was over and/or after seeing trial data. Claims ofclinically significant improvement may be open to interpretation, but false or misleading claims ofrecovery or remission from debilitating illness simply have no place in the scientific literature.

Tom KindlonInformation OfficerIrish ME/CFS Association

I hope Queen Mary University of London won't appeal again and cause more public money andresources to be spent on the case. Now that a court has ruled that the data is non-identifiable andthat releasing it will not contravene agreements with trial participants, there is no good reason tocontinue to withhold it. If QMUL appeal, people may suspect this case was at least partly abouttrying to hide inconvenient results. Indeed, the tribunal decision notice itself raised the question ofwhether QMUL may wish to avoid proper scrutiny of their trial.

Patients want nothing more than to recover from this condition, so misleading claims about recoveryrates are a particularly serious matter. Many are very sceptical of suggestions they can recover withtalk therapy or by steadily increasing their levels of exercise. This is not their experience.

Extraordinary claims require extraordinary evidence but the researchers have not yet released suchevidence: they revised all four aspects of the recovery criteria to make it much, much easier to beclassed as recovered and have so far failed to provide valid justifications for these changes. Some ofthe PACE Trial investigators have conflicts of interest, such as doing work for insurance companies,which can make people concerned about bias.

This is a huge victory for patients, who have a right to examine the evidence for the treatments thataffect their lives. I expect that the recovery rate will only be a small fraction of what the PACEresearchers claimed, due to the dramatic changes they made to the criteria.

Jane ColbyTymes Trust Executive Director

"Tymes Trust is pleased at the judge's ruling. We believe that, pending independent analysis of PACEdata, the MAGENTA (PACEstyle) study in children should be suspended immediately."

Press Release: U.C. San Diego, August 29, 2016. Chronic fatigue syndrome (CFS) is a mysterious and maddening condition, with no cure or known cause. But researchers at the University of California San Diego School of Medicine, using a variety of techniques to identify and assess targeted metabolites in blood plasma, have identified a characteristic chemical signature for the debilitating ailment and an unexpected underlying biology: It is similar to the state of dauer, and other hypometabolic syndromes like caloric restriction, diapause and hibernation.

Dauer is the German word for persistence or long-lived. It is a type of stasis in the development in some invertebrates that is prompted by harsh environmental conditions. The findings are published online in the August 29 issue of PNAS.

“CFS is a very challenging disease,” said first author Robert K. Naviaux, MD, PhD, professor of medicine, pediatrics and pathology and director of the Mitochondrial and Metabolic Disease Center at UC San Diego School of Medicine. “It affects multiple systems of the body. Symptoms vary and are common to many other diseases. There is no diagnostic laboratory test. Patients may spend tens of thousands of dollars and years trying to get a correct diagnosis.”

As many as 2.5 million Americans are believed to have CFS. It most often afflicts women in their 30s to 50s, though both genders and all ages can be affected. The primary symptom is severe fatigue lasting at least six months, with corollary symptoms ranging from muscle pain and headaches to sleep and memory problems.

Naviaux and colleagues studied 84 subjects: 45 men and women who met the diagnostic criteria for CFS and 39 matched controls. The researchers targeted 612 metabolites (substances produced by the processes of metabolism) from 63 biochemical pathways in blood plasma. They found that individuals with CFS showed abnormalities in 20 metabolic pathways. Eighty percent of the diagnostic metabolites measured were decreased, consistent with hypometabolic syndrome or reduced metabolism. The diagnostic accuracy rate exceeded 90 percent.

“Despite the heterogeneity of CFS, the diversity of factors that lead to this condition, our findings show that the cellular metabolic response is the same in patients,” said Naviaux. “And interestingly, it’s chemically similar to the dauer state you see in some organisms, which kicks in when environmental stresses trigger a slow-down in metabolism to permit survival under conditions that might otherwise cause cell death. In CFS, this slow-down comes at the cost of long-term pain and disability.”

Naviaux said the findings show that CFS possesses an objectively identifiable chemical signature in both men and women and that targeted metabolomics, which provide direct small molecule information, can provide actionable treatment information. Only 25 percent of the metabolite disturbances found in each person were needed for the diagnosis of CFS. Roughly 75 percent of abnormalities were unique to each individual, which Naviaux said is useful in guiding personalized treatment.

“This work opens a fresh path to both understanding the biology of CFS and, more importantly to patients, a robust, rational way to develop new therapeutics for a disease sorely in need of them.”

The study authors noted additional research using larger groups of participants from diverse geographical areas is needed to validate both the universality and specificity of the findings.

Funding for this research came, in part, from the UC San Diego Christini Fund, The Wright Family Foundation, The Lennox Foundation, the It Takes Guts Foundation, the UC San Diego Mitochondrial Disease Research Fund and gifts from Tom Eames and Tonye Marie Castenada.

At long last, Ampligen is approved somewhere. Not here, unfortunately, but it's a first step. With Argentinian approval, there is the possibility of approval elsewhere.

More to the point, in Argentina at least, there is official acknowledgement that ME/CFS is not a psychological illness.

__________________

Breakthrough Approval Provides Clear Path for Growth in Latin America and the European Union

PHILADELPHIA, Aug. 26, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the “Company” or “Hemispherx”), announced that it has received approval of its New Drug Application (NDA) from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The product will be marketed by GP Pharm, Hemispherx’s commercial partner in Latin America. We believe that rintatolimod is the first drug to receive approval for this indication anywhere in the world. We also believe that there are no other products in the pipeline for approval, worldwide, for this debilitating disease. A copy of the official approval from ANMAT, translated in English, is available on the Company’s website at http://ir.hemispherx.net/Events_Presentations.

The approval was based on submission of two pivotal studies, AMP-502 and AMP-516. Safety data also included additional CFS and non-CFS studies for a total of over 800 subjects including over 100 subjects with severe CFS who received Ampligen® for one year or longer. Several post-approval activities are required to be completed before product launch, including manufacturing site inspections and reimbursement evaluation by the Health Services Authority (SSS), the central health authority in Argentina. “Working closely with our partner in this effort, GP Pharm, our team at Hemispherx addressed all medical and scientific issues presented by ANMAT and deserves great credit for this major success. At Hemispherx, we may be small by big pharma standards, but our commitment to addressing this dire unmet medical need makes us mighty,” stated Hemispherx CEO Tom Equels.

Approval for commercial sale in Argentina provides a platform for potential commercial sales in certain countries within the European Union under regulations that support cross-border pharmaceutical sales of licensed drugs. Hemispherx and GP Pharm are now working to expand the approval of rintatolimod to additional countries with a focus on Latin America. In Europe, approval in a country with a stringent regulatory process in place, such as Argentina, adds further validation for the product as the Early Access Program (EAP) is launched in Europe.

“In Argentina, rintatolimod (Ampligen) has just been commercially approved for the severe disabling form of ME/CFS. The number of patients with ME/CFS is estimated to be over three million worldwide, however, only a portion of these have the severe and disabling form of the disease which we are targeting with this drug,” stated Tom Equels. “Until now, there has been no commercially available effective treatment and there are no advanced clinical candidates, other than rintatolimod, that we are aware of. This commercial approval in Argentina will dramatically improve our ability to treat patients suffering from severe ME/CFS in Latin America. We continue to work aggressively to clarify a path toward approval for those with severe ME/CFS in the United States, where we have Orphan Drug status, and therefore seven years of product exclusivity upon approval. We are greatly encouraged by this new regulatory approval in Argentina. This is the most significant accomplishment to date in Hemispherx’s plan to bring our drug to severe sufferers of ME/CFS worldwide.”

“We have worked diligently with Hemispherx to get to this point, and are now preparing for the commercial launch of rintatolimod for ME/CFS in Argentina,” commented Jorge Braver, chief executive officer of GP Pharm Latin America. “Looking ahead, we will continue to seek approval in additional Latin American countries.”

A letter in support of ME/CFS research to NIH Director Dr. Francis Collins, sponsored by two Representatives from California, is now circulating in Congress (House of Representatives) and we need as many U.S. Representatives as we can to be co-signers. Please CALL and send a FOLLOW-UP EMAIL to your U.S. Representative (not your Senators) and urge him or her to sign this letter. Complete instructions, including a phone and email script which you can personalize, can be found here. The number of calls to each Congressional office to make this request really matters. Your Representative may not be inclined to act as a result of one or two calls, but 10 calls will make a strong statement. Please call right away. The deadline for your Representative to sign the letter is this coming Wednesday, August 31.

This action is the result of months of hard work by #MEAction, Solve CFS/ME Initiative, and the U.S. Action Working Group Congressional Committee.

GET and CBT have been downgraded as treatments for ME/CFS as a result of follow up work by the Agency for Healthcare Research and Quality.In the initial Evidence Review prepared by AHRQ as input to the Pathways to Prevention (P2P) report commissioned by NIH, studies evaluating the effectiveness of Graded Exercise Therapy (GET) and Cognitive Behavioral Therapy (CBT) which used subjects meeting only the Oxford case definition (6 months of fatigue). Based on the initial inclusion of studies using the Oxford definition, notably the PACE trials, the Evidence Review suggested that GET and CBT were "moderately effective" treatments. The P2P report recommended that the Oxford definition no longer be used, and the PACE research has come under increasing criticism for its methodology.

As a result of advocates requests, AHRQ re-analyzed the evidence for GET and CBT, without including any studies based on the Oxford definition (e.g. PACE). The conclusion was that there was no evidence to suggest that GET or CBT were effective treatments for ME/CFS. Read more here.

This outcome is the direct result of repeated requests to AHRQ by advocates. Advocates' next step is to make sure that this change is strongly noted in future medical education materials, particularly the websites commonly used by doctors, such as the Centers for Disease Control and Prevention (CDC), Mayo Clinic and Up To Date.

I’m emailing with an urgent request regarding the disabling neuro-immune disease Myalgic Encephalomyelitis, also known as Chronic Fatigue Syndrome or ME/CFS.

Representatives Lofgren and Eshoo of California are sponsoring a letter to NIH Director Francis Collins in support of ME/CFS patients and research. ME/CFS costs the U.S. economy $17-24 billion annually; leaves its patients with lower quality of life scores than lung cancer, stroke, and rheumatoid arthritis; and has no known FDA-approved treatment or cure. Would you please support me and the 1 to 2.5 million Americans suffering from this disabling disease, by signing this letter? It would mean the world to me, my family, and other ME/CFS patients in our district to have your support.Please contact Angela Ebiner, Legislative Assistant for Rep. Zoe Lofgren (CA-19) at Angela.Ebiner@mail.house.gov or (202) 225-3072 to coordinate your participation. The letter’s deadline is 8/31.Thank you so very much for your support on this critical action. I look forward to your reply on this request at your earliest convenience.Warmest Regards,